Head of Pharmaceutical Quality

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Fulfil your potential in hospitals that make history:

Charing Cross, Hammersmith, St Mary's, Queen Charlotte's & Chelsea and Western Eye.

With five world-renowned hospitals, Imperial College Healthcare NHS Trust is full of opportunity if you are looking to develop your healthcare career.

We are an NHS Trust of approximately 16,000 people, providing care for over a million and a half patients from north west London and beyond every year.

We have a rich heritage and an ambitious vision for the future of our patients and local communities.

With our partners, Imperial College London, and The Royal Marsden NHS Foundation Trust, we form Imperial College Academic Health Science Centre, one of 6 academic health science centres in the UK, working to ensure the rapid translation of research for better patient care and excellence in education.

We are proud of our heritage in innovation and we are early adopters of new insights in technologies, techniques and treatments for improving health.

Job overview

We are seeking an experienced and exceptional Head of Pharmaceutical Quality to provide strategic leadership for Quality Assurance (QA) and Quality Control (QC) services across ICHT and LNWUH.

This senior, cross-Trust role holds overall responsibility for pharmaceutical and radio pharmacy quality systems, ensuring compliance with MHRA Specials and IMP manufacturing license's. QA/QC Services provided are across aseptics, sterile and non-sterile manufacture, pre-packing, radio pharmacy, and advanced medical therapies. The post holder will act as Quality Controller, providing assurance to Trust Boards and senior leadership on regulatory compliance, inspection readiness and patient safety.

This is a rare opportunity to shape pharmaceutical quality services at scale within two leading NHS Trusts, with strong links to research, innovation and regional collaboration.

Main duties of the job

• Provide strategic and professional leadership for QA and QC services across both Trusts
• Act as Quality Controller on MHRA Specials manufacturing license's for Pharmacy and Radio pharmacy
• Ensure robust, GMP-compliant quality systems support pharmaceutical and radiopharmaceutical manufacturing
• Provide expert assurance to senior management on regulatory compliance and inspection readiness
• Lead engagement with regulators, including the MHRA, and represent the Trusts during inspections and audits
• Oversee validation lifecycle management for facilities, equipment, processes and analytical methods
• Lead and develop multidisciplinary QA and QC teams across two Trusts, including workforce planning and training
• Champion research, innovation and clinical trials, ensuring QA/QC compliance with GMP and GCP
• Act as a senior advisor on pharmaceutical quality, patient safety, unlicensed medicines and risk management
• Manage budgets and resources for Quality Services in line with Trust governance and financial requirements
• Act as a senior leader across the pharmacy department and pharmacy senior leadership team

Working for our organisation

At Imperial College Healthcare you can achieve extraordinary things with extraordinary people, working with leading clinicians pushing boundaries in patient care.

Become part of a vibrant team living our values - expert, kind, collaborative and aspirational. You'll get an experience like no other and will fast forward your career.

Benefits include career development, flexible working and wellbeing, staff recognition scheme. Make use of optional benefits including Cycle to Work, car lease schemes, season ticket loan or membership options for onsite leisure facilities.

We are committed to equal opportunities and improving the working lives of our staff and will consider applications to work flexibly, part time or job share. Please talk to us at interview. .

Detailed job description and main responsibilities

The full job description provides an overview of the key tasks and responsibilities of the role and the person specification outlines the qualifications, skills, experience and knowledge required. For both overviews please view the Job Description attachment with the job advert.

Person specification

Education

Essential criteria

• Master's degree in pharmacy or in science-based discipline or equivalent experience
• Specialist higher diploma (Masters) in Technical Services (e.g. National course in Pharmaceutical Technology & Quality Assurance) or equivalent experience

Desirable criteria

• Management qualification MBA
• Doctorate in relevant field
• EU Qualified Person status or eligible to be a QP or QP/IMP

Experience

Essential criteria

• Extensive specialist knowledge & experience particularly in the manufacturing and release of: o Sterile injectable manufacture o Manufacture of Special (unlicensed) medicinal products o Radiopharmacy
• Extensive Quality Managerial experience in a specials / Licensed Pharmaceutical manufacturing facility and experience of hosting Regulatory and Corporate/Regional audits
• Previous role and experience as Person Responsible for Quality Control on the MHRA Specials manufacturing licence.
• Significant experience in the design, building and commissioning and validation of equipment, new or major upgrade of Production facilities or QC Laboratory, and manufacturing processes.
• Extensive experience as a Releasing Officer for manufactured medicinal products in a specials / licensed manufacturing unit
• Highly effective leadership including previous evaluated experience of coaching junior QA staff, mentorship and training skills, in addition to a strong track record in engaging with and influencing senior decision makers

Desirable criteria

• Experience of Research and supply of IMP medicines for clinical trials

Skills

Essential criteria

• Demonstrated expert knowledge of GCP, GMP, GLP, QA and all current relevant regulations plus technical knowledge of pharmaceutical QA and GMP with a proven ability to apply this knowledge to develop and maintain quality systems
• Demonstrated ability to identify and manage risks and ability to make quality-based decisions on batch disposition.
• Demonstrated evidence of being able to manage change with QA/Production services and to evaluate and improve service quality.
• Demonstrated expert knowledge of the validation requirements for pharmaceutical facilities, equipment, analytical procedures and products.
• Demonstrated good understanding of key NHS objectives and publications especially with regards to Specials Manufacturing.

Desirable criteria

• Demonstrated ability to ensure quality through the set-up, manufacturing and release of IMPs under a MAIMP to comply fully with the requirements of GMP and GCP.

Right to work

If you need sponsorship to work in the UK, please visit the Home Office website for information on sponsorship and visa status before you fill in your application form. Due to recent changes in the UK immigration rules which affect Skilled Worker Visas, Global Business Mobility, Higher Skill Level and Increased Salary Thresholds, please ensure that you are able to meet the requirements to live and work in the UK before applying. Further information about eligibility is available on UK Visas and Immigration - GOV.UK

Please ensure you check your emails regularly as this is how we will communicate with you throughout the recruitment process. If you are shortlisted you will be contacted by email and text message (if you provide a mobile contact number).

Employer certification / accreditation badges

Applicant requirements

You must have appropriate UK professional registration.

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Documents to download

• Job Description (PDF, 894.5KB)
• Functional Requirements (PDF, 272.6KB)
• Our Strategy 2023-25 (PDF, 230.4KB)